SAS RSV CONTROL KIT

K030628 · Sa Scientific, Inc. · JJX · Mar 17, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030628
• Device Name: SAS RSV CONTROL KIT
• Applicant: Sa Scientific, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

SAS™ RSV Control Kit are controls for use with the SAS™ RSV Test Kit. The test is for professional use.

Device Story

SAS™ RSV Control Kit functions as quality control material for the SAS™ RSV Test Kit. Used by laboratory professionals in clinical settings to verify test performance. Provides known positive and negative results to ensure assay accuracy and reliability. Does not perform diagnostic analysis itself; serves as a reference standard for the associated RSV test kit.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Quality control material for in vitro diagnostic use. Class I device (21 CFR 862.1660). Product code JJX.

Indications for Use

Indicated for professional use as quality control material for the SAS™ RSV Test Kit.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them that could represent water or movement.

MAR 1 7 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Ricardo R. Martinez Director of Regulatory Affairs SA Scientific, Inc. 4919 Golden Quail San Antonio, TX 78240

Re: k030628

Trade/Device Name: SASTM RSV Control Kit Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJX Dated: February 25, 2003 Received: February 27, 2003

Dear Mr. Martinez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

Applicant: SA Scientific, Inc. 4919 Golden Quail San Antonio, TX. 78240 Ph: [phone] Fax: [phone]

Establishment Reg. No.: 1645225

501(k) Number: K030628

Device Names:

SAS™ RSV Control Kit

Indications for Use:

SAS™ RSV Control Kit are controls for use with the SAS™ RSV Test Kit.

The test is for professional use.

(Please do not write below this line)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109) Division Sign-Off)

| Division of Clinical Laboratory Devices |
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| 510(k) Number |

| Prescription Use | <b>X</b> | or | Over-the-Counter |
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